Halyard convenience kits containing Medline Namic manifolds recalled due to particulates
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds that may have particulates in the fluid path.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Plain-English summary
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits that contain Medline Namic Angiographic Star Off Handle Manifolds. These kits were distributed nationwide in the states of North Carolina and Texas.
The recall was initiated because particulates may be present within the fluid path of the manifolds. These particles have the potential to be introduced into a patient's blood circulation and become lodged within blood vessels.
Users should check their inventory for the affected kits and lot numbers to determine if they are part of this recall.
The recalled product
- Product
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 5,168
Distribution
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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